Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study

Anorexia Nervosa Clinical Trial

— APANOR  

Official title:

Effects of Adapated Physical Activity Program on Kynurenin Metabolism During Refeeding in Anorexia Nervosa : APANOR Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04817436
• Other study ID #: 2017/0383/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2021
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Physical hyperactivity is often associated to anorexia nervosa (AN). Data suggest common central pathways between hyperactivity and anorexia. Maintaining adapted physical activity (APA) during refeeding in AN is controversial. Many studies suggest beneficits of APA in AN on body composition (increase fat free mass and better distribution of fat mass), mood regulation, bone metabolism. We recently reported benefits of maintaining physical activity during refeeding in a mice model of anorexia (activity-based anorexia model). These benefits involved the tryptophan-kynurenin pathway. Thus, we aim in the APANOR study to assess effects of APA during refeeding in AN on kynurenin metabolism.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female

2. Patient > 18 years

3. Follow-up in the department of clinical Nutrition of Rouen

4. BMI =15,0 and <18,5 kg/m²

5. Diagnosis of anorexia nervosa according to DSM-V classification

Exclusion Criteria:

1. Physical activity contraindications : hemodynamic disorder, uncontrolled cardiovascular disease, intracranial hypertension

2. Patients with poor understanding of spoken or written French

3. Person deprived of their liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults

4. Person subject to a safeguard of justice, guardianship or curatorship.

5. Pregnant or breastfeeding woman

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• physical activity program (APA)
adapted physical activity program (APA)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effects of adapated physical activity (APA) program on kynurenin metabolism	Variation of plasmatic kynurenin acid between V1 and V2 in patients undergoing APA during refeeding versus other patients (control group without APA)	3 months
Secondary	To evaluate the effects of adapated physical activity program on anthropometric data.	Anthropometric data	3 months
Secondary	To evaluate the involving of gut microbiota composition and diversity	gut microbiota analyses	3 months
Secondary	To evaluate the effects of adapated physical activity program on quality of life	Self-administered questionnaires assessing the quality of life	3 months
Secondary	To evaluate the involving of auto-antibodies against neuropeptides involved in food intake regulation	Dosage of auto-antibodies against neuropeptides involved in food intake regulation using ELISA method (enzyme-linked immunosorbent assay)	3 months
Secondary	To evaluate the effects of adapated physical activity program on Body composition (fat mass, fat free mass)	Mesaurement of fat and free mass	3 months